The invention relates to a process for rapidly diagnosing a malignant disease or the precursor stages thereof from blood samples including arterial and venous blood.
For the diagnosis of malignant diseases imaging procedures such as X-ray, ultrasound, computer tomography, core spin tomography and also histological examinations of biopsis material, antibody tests and tests for more or less specific tumor markers are utilized. The last mentioned tests are performed with histological preparations and also with blood serum. The tumor markers are generally very specifically indicative only for certain types of tumors.
Problems generally occur in that these procedures have only an unsatisfying accuracy and cannot distinguish sufficiently clearly between malignant and benign types and precursor stages. For a safe diagnosis, several of these procedures are generally needed. Some of the imaging procedures involve substantial radiation exposure; and the biopsy represents a surgical procedure, which may even result in a spreading of tumor cells. In addition, these procedures are all relatively expensive. In some cases, reliable results are available only after several days of continuous evaluation.
Printed publication (1) discloses a process for the diagnosis of malignant diseases wherein arterial and venous blood of a patient is examined. In this process, the various cell populations and/or sub-populations are determined and the results of these determinations for venous and arterial blood are compared.
It is the object of the present invention to provide a rapid and economic process for diagnosing malignant diseases and their precursor stages which does not rely on imaging procedures and which can be performed in a laboratory in a simple, fast and inexpensive way.
In a process for rapidly and inexpensively diagnosing malignant diseases or their precursor stages, samples of arterial and/or capillary blood and of venous blood are withdrawn from a patient and the percentage shares of three groups of blood cells in the blood samples are determined wherein a first group includes blood cells of a size xe2x89xa68 xcexcm, a second group includes blood cells of a 9 xcexcm and 10 xcexcm and the third group includes blood cells of a size xe2x89xa711 xcexcm. The percentage shares are multiplied by weighting factors xcex11 and xcex21, and the values
y=xcexa3xcex1i[(Ni)A]xe2x88x92xcexa3xcex1i[(Ni)V]
and
x=xcexa3xcex2i[(Ni)A]xe2x88x92xcexa3xcex2i[(Ni)V],
are calculated and from the locations of x and y in an x/y coordinate system, the presence of Ca. corp. uteri or its precursor stages is determined.
With the process according to the invention peripheral blood cells, preferably the lymphocyte population is examined. These cells are removed from the organism with arterial and/or capillary blood. The arterial blood can be taken from a peripheral artery. Instead of arterial blood, capillary blood can be used which can be taken from a fingertip or an earlobe of a patient.
In addition, venous blood is taken for example from an arm vein of a patient. The arterial blood and/or the capillary blood as well as the venous blood are examined outside the body. For the blood examination a standard blood smear test is suitable. In the test, size ratios of groups of the cells, particularly lymphocytes, are determined and are subjected to a mathematical analysis.
For performing the process, blood smears may be prepared on a microscope slide from the blood taken from an artery and/or a capillary such as the fingertip and from the blood taken from a vein. The blood cells can be dried, fixed and stained by standard procedures.
Thereafter, a size histogram of arterial and/or capillary (index A) and venous (index V) blood cells, preferably of the lymphocyte population is prepared. This can be done by microscopic measurement of diameters of about 200 blood cells, particularly about 200 lymphocytes from the smear. To this end, the respective percentage content (Ni)A or, respectively, (Ni)V in the three size ranges (1)xe2x89xa68 xcexcm, preferably 6 xcexcm to 8 xcexcm, (2) 9 xcexcm and 10 xcexcm and (3)xe2x89xa711 xcexcm, preferably 11 xcexcm to 16 xcexcm are determined with an accuracy of 1 xcexcm (that is the blood cell diameter values are rounded to the nearest xcexcm number). This is done in such a way that, for each of the three cell size groups in the total range of from about 6 xcexcm to 16 xcexcm in the arterial ({circumflex over ( )}) as well as in the venous blood (V) the percentage content (Ni)A, or respectively, (Ni)V of each of the three size ranges of the total number of the respective blood cell type is determined.
Lymphocytes  less than 6 xcexcm and  greater than 16 xcexcm are generally present only in small numbers. Besides the measurement of smear samples any other procedure is suitable whereby the percentage shares of the three groups corresponding to the size ranges mentioned on the basis of the respective blood cell type can be determined.
The percentage shares of blood cells of the respective group are multiplied by weighting factors. In a first step, initially the percentage shares of the arterial and/or the capillary blood as well as the percentage shares of the venous blood are multiplied by a first weighting factor xcex1i which preferably for the first group of xe2x89xa68xcexcm has the value 4, for the second group of 9 xcexcm and 10 xcexcm has the value 2, and for the third group of xe2x89xa711 xcexcm has the value 4.
In any case, the weighting factors xcex1i for the first and the third groups should be essentially the same whereas the weighting factor for the second group is smaller.
In this way, the values of xcex1i[(Ni)A] (arterial blood and (or capillary blood) and xcex1i[(Ni)V] (venous blood) are obtained for the first, the second and the third group.
The values of xcex1i[(Ni)A] and xcex1i[(Ni)V] of the first, second and third group are added up whereby xcexa3xcex1i[(Ni)A] and xcexa3xcex1i[(Ni)V] are obtained.
In an analog manner, subsequently the percentage shares of the arterial and/or capillary blood [(Ni)A] and also the percentage shares of the venous blood [(Ni)V] are multiplied by a second weighting factor xcex2i, which preferably
for the first group of xe2x89xa68 xcexcm has the value 8,
for the second group of 9 xcexcm and 10 xcexcm has the value 4, and
for the third group of xe2x89xa711 has the value 2. With the selection of other weighting factors xcex2i, it has to be taken into consideration that the numerical value of the weighting factors xcex2i of the first group is the highest and is the smallest for the third group. In this way, the value of xcex2i[(Ni)A] and xcexa3xcex2i[(Ni)V] are obtained for the first, second and third group.
The values of xcex2i[(Ni)A] and xcex2i[(Ni)V] of the first, the second and the third group are added up whereby xcexa3xcex2i[Ni)A] and xcexa3xcex2i[(Ni)V] are obtained.
Subsequently, the differences
X=xcexa3xcex2i[(Ni)A]xe2x88x92xcexa3xcex2i[(Ni)V].
X=xcexa3xcex2i[(Ni)A]xe2x88x92xcex2i[(Ni)V]
are calculated. The values for x and y represent for a particular patient characteristic values which can be plotted graphically in an x/y coordinate system as a point. From the position of the point, it can be concluded whether the patient is healthy, is in a precursory cancer stage, particularly a fibromyoma, or has uterus cancer (Ca. corp uteri).
The invention will be described below in greater detail on the basis of the accompanying drawing.